MAUDE Adverse Event Report: BOSTON SCIENTIFIC EMERGE MONORAIL; BALLOON DELIVERY SYSTEM, 3.0 MM X 20 MM

Device Problems Fracture (1260); Difficult to Remove (1528); Physical Resistance (2578)

Patient Problem Reocclusion (1985)

Event Date 01/18/2014

Event Type  Injury  

Event Description

Patient had a cerebral arteriogram and basilar artery endovascular angioplasty with stent and ia tpa for a basilar artery stroke in light of high grade basilar artery stenosis.A boston scientific emerge monorail 3.0 mm x 20 mm balloon delivery system and neuroscout 0.014 inch microwire construct was inserted into the sca.The guide catheter was then advanced to the left vertebral artery under fluoroscopic guidance.The microwire was positioned to the right sca vessel.The balloon was advanced to the level of the area of maximal stenosis within the basilar artery.The balloon was inflated to nominal pressure.The balloon was deflated.Attempts to retract the microwire from the right sca were met with resistance.Fluoroscopic imaging identifies the presence of the microwire snagged within the right sca.Multiple maneuvers were performed in an attempt to dislodge the microwire from the right sca.After a significant amount of time engaging in multiple maneuvers to dislodge this microwire.The microwire was then placed under tension which resulted in intentional fracture of the microwire.This fractured microwire and balloon delivery system was then retrieved from the shuttle sheath over the guide catheter.Add'l angiographic imaging identified reocclusion of the basilar artery.The boston scientific emerge monorail 3.0 mm x 20 mm balloon delivery system and a new 0.014 inch microwire construct were inserted with the guide catheter advanced into the left vertebral artery under fluoroscopic guidance.Reason for use: basilar artery stroke in light of high-grade basilar artery.

• Brand Name: EMERGE MONORAIL
• Type of Device: BALLOON DELIVERY SYSTEM, 3.0 MM X 20 MM
• Manufacturer (Section D): BOSTON SCIENTIFIC
• MDR Report Key: 3866735
• MDR Text Key: 19556948
• Report Number: MW5036510
• Device Sequence Number: 1
• Product Code: LIT
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 05/30/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/04/2014
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Patient Sequence Number: 1
• Treatment: CRESTOR 10 MG DAILY.; CIALIS 20 MG Q.36 HOURS P.R.N.; ZETIA 10 MG DAILY.; ASPIRIN 81 MG DAILY.; VITAMIN B COMPLEX DAILY.; VIAGRA 100 MG DAILY P.R.N.; LISINOPRIL 40 MG DAILY.
• Patient Outcome(s): Hospitalization
• Patient Age: 64 YR
• Patient Weight: 95